Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tuttnauer Co. , Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
132 daysmedian FDA review time
526 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111736 | TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES | Tuttnauer Co. , Ltd. | 2011-12-08 | 171 | 0 |
| K063711 | TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1 | Tuttnauer Co. , Ltd. | 2007-02-02 | 50 | 0 |
| K003470 | EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870 | Tuttnauer Co. , Ltd. | 2001-02-20 | 104 | 0 |
| K920478 | TUTTNAUER LSI (AUTOMATIC) | Tuttnauer Co. , Ltd. | 1993-07-08 | 526 | 0 |
| K850264 | TUTTNAUER PRE-VACUUM AUTOCLAVE | Tuttnauer Co. , Ltd. | 1985-06-04 | 132 | 0 |
| K833837 | AMERICAN GOLD SERIES AUTOCLAVE | Tuttnauer Co. , Ltd. | 1984-01-11 | 69 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda